Rugstad H E, Hundal O, Holme I, Herland O B, Husby G, Giercksky K E
Clin Rheumatol. 1986 Sep;5(3):389-98. doi: 10.1007/BF02054259.
Piroxicam and naproxen plasma concentrations were obtained after 4 weeks active therapy between 3 and 12 hours post-dose in 640 and 629 patients, respectively. These patients are a subset of 2,035 patients with osteoarthritis on whom we have reported previously (11) in a double-blind multicentre safety and efficacy trial comparing piroxicam 20 mg/day and naproxen 750 mg/day. The purpose of the present study was to look for an association of plasma drug concentration with the variables of: age, sex, adverse events and efficacy. There was a statistically significant increase in plasma concentrations of both drugs with increasing age and females had higher concentrations than males. The increase in plasma concentration seen with increasing age was of a magnitude of 25% for piroxicam and 20% for naproxen when comparing a 50 year old to an 80 year old. However, less than 15% of the variability in plasma concentrations seen between patients is accounted for by age and sex. Within the plasma concentrations achieved with these doses, no association with adverse events, non-serious or serious, and efficacy was noted.
在分别对640例和629例患者进行4周的积极治疗后，于给药后3至12小时测定了吡罗昔康和萘普生的血浆浓度。这些患者是2035例骨关节炎患者中的一部分，我们之前曾在一项比较每日20毫克吡罗昔康和750毫克萘普生的双盲多中心安全性和疗效试验中对这2035例患者进行过报道(11)。本研究的目的是寻找血浆药物浓度与以下变量之间的关联：年龄、性别、不良事件和疗效。两种药物的血浆浓度均随年龄增长而有统计学意义的升高，且女性的浓度高于男性。将50岁患者与80岁患者进行比较时，吡罗昔康血浆浓度随年龄增长的增幅为25%，萘普生为20%。然而，患者之间血浆浓度差异中不足15%可由年龄和性别解释。在这些剂量所达到的血浆浓度范围内，未发现与不良事件（非严重或严重）及疗效有关联。
